Tamper evident overap of a container

Abstract

A tamper evident protective cap for a container having a pharmaceutical or biological fluid. The barrel of the container is equipped with two protuberances. The protective cap consisting of top and bottom portions are connected by a frangible portion. The bottom portion contains two notches to engage the protuberances. Without engaging the protuberances with the notches the protector cap cannot be removed. Upon engaging the protuberances with the notches, the top portion of the protective cap is twistably removed at the frangible area and the content of the container is removed by attaching a luer connector or a syringe equipped with a luer connector.

What is claimed is:  
     
       1. A combination of a tamper evident protective cap and a pre-filled glass or plastic syringe or cartridge barrel or a tube stoppered by an elastomeric closure at its tapered distal end wherein said syringe or cartridge barrel or tube comprises: 
       a) a cylindrical chamber having a tapered distal end terminating in a tip having a bore therethrough, said bore is stoppered by an elastomeric closure, said cylindrical chamber containing a liquid therein, wherein said tip is equipped with a female luer connector to which a male luer connector may be attached;  
       b) a pair of protuberances at the tapered distal end on the opposite sides of the barrel designed to receive and engage a pair of notches on the proximal end of a tamper evident protective cap;  
       c) a ring on the tapered distal end of the barrel spaced between said pair of protuberances and said female luer connector;  
       d) wherein said tamper evident protective cap is removably engaged with said tapered distal end of said syringe or cartridge barrel or tube and comprises:  
       a cylindrical top portion and a cylindrical bottom portion connected by a frangible area allowing the top portion to be removed from the bottom portion, wherein: said cylindrical top portion terminates in a flat circular surface conforming to said elastomeric closure in said tip of the syringe or cartridge barrel or tube; said bottom portion terminates in an open end comprising a flange extending inwardly designed to engage the ring such that the engagement prevents removal of the tamper evident protective cap; and a pair of notches on the proximal end of said tamper evident protective cap engaging said pair of protuberances on the tapered distal end of the syringe or cartridge barrel or tube, wherein upon engagement of said pair of notches with said pair of protuberances on the top portion of said tamper evident protecting cap is twistably separated from the bottom portion thereof thereby exposing the tapered tip along with the elastomeric closure and female luer connector ready for withdrawal of said liquid from said syringe or cartridge barrel or tube.  
     
     
       2. The combination of a tamper evident protective cap and a pre-filled glass or plastic syringe or cartridge barrel or a tube of  claim 1  wherein said cylindrical bottom portion is slightly larger than said cylindrical top portion and separated by said frangible portion therebetween. 
     
     
       3. The combination of a tamper evident protective cap and a pre-filled glass or plastic syringe or cartridge barrel of a tube of  claim 1  wherein said cylindrical bottom portion and said cylindrical top portion are of the same size separated by said frangible portion therebetween. 
     
     
       4. The combination of a tamper evident protective cap and a pre-filled glass or plastic syringe or cartridge barrel or a tube of  claim 1  wherein said ring on the tapered distal end of the barrel prevents removal of said tamper evident protective cap prior to separation of said bottom and top portions of said tamper evident protective cap. 
     
     
       5. The combination of a tamper evident protective cap and a pre-filled glass or plastic syringe or cartridge barrel or a tube of  claim 1  wherein said tamper evident protective cap is made of a polymer material selected from the group consisting of polyethylene, polypropylene, polystyrene, polycarbonate, polymethylpentene, cyclic olefin co-polymers, acrylic polymers and methacrylic polymers. 
     
     
       6. The combination of a tamper evident protective cap and a pre-filled glass or plastic syringe or cartridge barrel or a tube of  claim 1  wherein said liquid in said syringe or cartridge barrel or tube is a pharmaceutical or biological liquid. 
     
     
       7. The combination of a tamper evident protective cap and a syringe or cartridge barrel or a tube of  claim 6  wherein said pharmaceutical or biological liquid is sterilized. 
     
     
       8. The combination of a tamper evident protective cap and a pre-filled syringe or cartridge barrel or a tube of  claim 7  wherein said sterilization is by autoclave. 
     
     
       9. The combination of a tamper evident protective cap and a pre-filled syringe or cartridge barrel or a tube of  claim 1  wherein said elastomeric closure is a soft rubber stopper. 
     
     
       10. A method of delivering a pharmaceutical or biological liquid to a patient from a pre-filled glass or plastic syringe or cartridge barrel or tube equipped with a tamper evident protective cap comprising providing a combination of a tamper evident protective cap and a pre-filled syringe or cartridge barrel or tube, wherein said delivery comprises the steps of: 
       A) providing a glass or plastic syringe or cartridge barrel or tube containing a pharmaceutical or biological liquid therein, said syringe or cartridge barrel or tube comprising:  
       a) a cylindrical chamber having a tapered distal end terminating in a tip having a bore therethrough, said bore is stoppered by an elastomeric closure, wherein said tip is equipped with a female luer connector to which a male luer connector is attached;  
       b) a pair of protuberances at the tapered distal end on the opposite sides of the barrel designed to receive and engage a pair of notches on the proximal end of a tamper evident protective cap;  
       c) a ring on the tapered distal end of the barrel spaced between said pair of protuberances and said female luer connector;  
       d) wherein said tamper evident protective cap is removably engaged with said tapered distal end of said syringe or cartridge barrel or tube and comprises:  
       a cylindrical top portion and a cylindrical bottom portion connected by a frangible area allowing the top portion to be removed from the bottom portion, wherein: said cylindrical top portion terminates in a flat circular surface conforming to said elastomeric closure in said tip of the syringe or cartridge barrel or tube; said bottom portion terminates in an open end comprising a flange extending inwardly designed to engage the ring such that the engagement prevents removal of the tamper evident protective cap; and a pair of notches on the proximal end of said tamper evident protective cap engaging said pair of protuberances on the tapered distal end of the syringe or cartridge barrel or tube, wherein upon engagement of said pair of notches with said pair of protuberances on the top portion of said tamper evident protecting cap is twistably separated from the bottom portion thereof thereby exposing the tapered tip along with the elastomeric closure and female luer connector ready for withdrawal of said liquid from said syringe or cartridge barrel or tube;  
       B) engaging said pair of notches with said pair of protuberances on the top portion of said tamper evident protective cap;  
       C) separating said top portion from said bottom portion of the protecting cap by twisting thereby exposing the tapered tip along with the elastomeric closure and female luer connector;  
       D) removing the elastomeric closure from the tip of the syringe or cartridge barrel or tube;  
       E) connecting a male luer connector or a syringe equipped with a male luer connector to the female luer connector; and  
       F) delivering the pharmaceutical or biological liquid to the patient by advancing a plunger in said syringe or cartridge barrel or tube towards the distal end thereof.  
     
     
       11. The method of  claim 10  wherein said pharmaceutical or biological liquid is an x-ray contrast medium.